Reversal of Remimazolam by a Single Dose of Flumazenil

NCT05382806 | Completed

• 1 other identifier: KUMC2021-11-058
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

Remimazolam, a brand-new sedative which has benzodiazepine property. It is an ultra-short acting sedative and regarded as a proper drug for procedural sedation.

Conditions

Flumazenil Adverse Reaction; Ambulatory Surgery; Postoperative Nausea; Remimazolam

Outcome Measures

Primary Outcomes (1)

• the incidence of postoperative nausea and vomiting (PONV)

  assess PONV with ordinal scale; 0=none, 1= nausea, 2= retching, 3=vomiting

  up to 24 hours after participants discharge from day surgery center.

Study Arms (2)

group Control

PLACEBO COMPARATOR

participants are administered 2mL of 0.9% placebo at the end of procedure.

Drug: Flumazenil

group Flumazenil

ACTIVE COMPARATOR

participants are administered 0.2mg (2mL) of flumazenil at the end of procedure.

Drug: Flumazenil

Interventions

Flumazenil DRUG

During the procedure, continuous infusion of remimazolam dose of 2mg/kg/hr. when procedure ends, infusion remimazolam stops and 0.9% normal saline or 0.2mg of flumazenil according to allocated groups.

Also known as: placebo

group Control; group Flumazenil

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participants aged over 20 years scheduled for ambulatory gynecologic surgery.

You may not qualify if:

• allergy or hypersensitivity to flumazenil, benzodiazepines, NSAIDs, 5-HT3
• arrhythmia, myocardial infarction, coronary artery disease
• obstructive sleep apnea
• severe or acute respiratory distress
• tricyclic anti-depressant
• lactose intolerance
• BMI over 30kg/m2
• ASA classification 4 or 5

Sponsors & Collaborators

• Konkuk University Medical Center: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, Seoul-T'ǔkpyǒlshi, 05030, South Korea

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Flumazenil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Seong-Hyop Kim, M.D. Ph.D

  Konkuk University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: participants and outcome assessors are blinded to which group participants are allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are administered either flumazenil (group flumazenil) or 0.9% normal saline (group control).

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 19, 2022
• Study Start: August 2, 2022
• Primary Completion: May 10, 2023
• Study Completion: May 13, 2023
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)